Stent-graft with proximal and distal attachment, delivery catheter and methods of making same

ABSTRACT

A metallic or pseudometallic covered stent in which the stent component and the cover component are each fabricated of biocompatible metallic or pseudometallic materials, in which the cover and the stent are joined by at least one juncture at each of a proximal and distal end of the stent and the cover. A method of joining the stent and the cover is also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present invention claims priority, as a divisional application, toU.S. patent application Ser. No. 11/215,984, which was filed on Aug. 31,2005, and the aforementioned patent application is incorporated byreference in its entirety.

BACKGROUND OF THE INVENTION

The present invention pertains generally to implantable medical devicesand, more particularly, to implantable medical devices which are capableof being implanted utilizing minimally-invasive delivery techniques.More particularly, the present invention relates to covered stents,stent-grafts and stent-graft-type devices that are implanted intoanatomical passageways using minimally invasive delivery techniques.More specifically, the present invention comprises covered stents,stent-grafts and stent-graft-type devices that are fabricated entirelyof biocompatible metals or of biocompatible materials which exhibitbiological response and material characteristics substantially the sameas biocompatible metals, such as for example composite materials(hereinafter referred to as “pseudometals” or by the property of being“pseudometallic”). Most specifically, the present invention relates tometal stents and metal stent covers wherein the metal stent cover isattached by at least one juncture between the metal stent at each ofproximal and distal ends thereof.

Stents are typically lattice structures capable of adopting both adiametrically compressed configuration, for delivery to the site ofdeployment, and a diametrically expanded configuration, in which thestent presses outward and against the inner wall of the anatomicalpassageway to provide structural support to the vessel, restore andmaintain vascular patency. Endoluminal stents, for example, arefrequently used post-angioplasty to provide a structural support for ablood vessel and reduce the incidence of restenosis followingpercutaneous balloon angioplasty. For example, endovascular stents maybe introduced to a site of disease or trauma within the body'svasculature from an introductory location remote from the disease ortrauma site using an introductory catheter, passed through thevasculature communicating between the remote introductory location andthe disease or trauma site, and released from the introductory catheterat the disease or trauma site to maintain patency of the blood vessel atthe site of disease or trauma.

In many applications, it is desirable to provide a stent with a coveringcapable of conferring particularly desirable properties that the stentalone does not possess. For example, bare stents have been associatedwith significant restenosis rates and, due to the typically largefenestrations in the walls of the stent required to accommodate stentexpansion from the compressed to the expanded diametric stage, permitparticulate material, such as fragmented plaque, to pass from the vesselwall into the bloodstream. The relatively large fenestrations permitparticulate material resident on the vascular walls, such as friableplaque or embolic material, to pass through the fenestrations and intothe general circulation. Such undesirable effects may be reduced,however, by providing the stent with a covering over either the lumenalor ablumenal surfaces, or both surfaces, thereby forming a covered-stentor for purposes of this application, synonymously, a stent-graft.

SUMMARY OF THE INVENTION

In accordance with the present invention, a covered stent havingproximal and distal affixation points between the stent and the covercomponents is provided.

Additionally, a method of attaching the cover to the stent is providedin which the stent is loaded into a restraining sheath having a pusherassembly concentrically engaged in the restraining sheath; the stent isloaded to a depth within the restraining sheath which permits theproximal end of the stent to remain exposed from the end of therestraining sheath; the cover is concentrically engaged about the outercircumference of the restraining sheath and aligned such that theproximal end of the cover is in concentric alignment with the proximalend of the stent;

a proximal affixation is created between the proximal end of the stentand the proximal end of the cover; the restraining sheath is thenpositioned in co-axial alignment with a distal end of a constrainingtube, and the pusher assembly actuated to push the stent and theproximally affixed cover into the distal end of the constraining tube toa point where the distal end of the stent and the distal end of thecover are exposed; a distal affixation is created between the distal endof the stent and the distal end of the cover, and the now proximally anddistally affixed stent and cover are passivated and subsequentlypositioned in co-axial alignment with a distal end of a constrainingtube, and a pusher assembly actuated to push the stent and theproximally affixed cover into the distal end of the delivery catheterlumen; a pusher assembly is then loaded into the delivery catheter fromthe proximal end of the catheter, and a guidewire and atraumatic tip isloaded in retrograde fashion from the distal end of the deliverycatheter.

The foregoing summary, as well as the following detailed description ofpreferred embodiments of the invention, will be better understood whenread in conjunction with the appended drawings. For the purpose ofillustrating the invention, there is shown in the drawings embodimentswhich are presently preferred. It should be understood, however, thatthe invention is not limited to the precise arrangements andinstrumentalities shown.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1D present sequential side-elevational cross-sectional viewsdepicting a loading assembly in accordance with an inventive apparatusand method for preparing a proximally-joined covered stent assembly.

FIGS. 2A-2B present sequential side-elevational cross-sectional views ofa transfer assembly in accordance with the inventive apparatus andmethod for preparing a proximally- and distally-joined covered stentassembly.

FIGS. 3A-3C presents sequential side-elevational cross-sectional viewsdepicting loading of the inventive proximally and distally-joinedcovered stent assembly into a delivery catheter.

FIGS. 4A-4B presents sequential side-elevational cross-sectional viewsdepicting loading of a proximally- and distally-joined covered stentassembly into a tapered catheter sheath in accordance with analternative preferred embodiment of the present invention.

FIGS. 5A-5B presents sequential side-elevational cross-sectional viewsdepicting catheter assembly in accordance with the alternative preferredembodiment of the present invention.

FIG. 6A is an expanded side view of the stent with proximal and distaljunction points; and FIG. 6B is an enlarged side view of the stent withthe proximal and distal junction points.

FIG. 7 is a photomicrograph illustrating a junction point of a stentwelded to a cover.

DETAILED DESCRIPTION OF THE INVENTION

Turning now to the accompanying figures, FIGS. 1A-1D depict thepreparation of a proximally-joined covered stent using a loading/weldingfixture 40. FIG. 1A depicts the loading of stent 10 into the lumen ofloading sheath 30 of loading/welding fixture 40. Loading/welding fixture40 consists generally of the cylindrical loading sheath 30 and a pusherrod 32 having an abutment member 34 coupled to one end of the pusher rod32. The abutment member 34 is concentrically engaged within the lumen ofloading sheath 30 and is capable of reciprocal movement therein. Theabutment member 34 and pusher rod 32 serve dual functions: first, theabutment member 34 acts as a stop during insertion of the stent 10 intothe lumen of the loading sheath 30 to properly position the stent 10therein, and second, the pusher rod 32 and abutment member 34 act toeject the proximally-affixed stent and cover from the lumen of theloading sheath 30.

FIG. 1B depicts the loading of cover 20 over an ablumenal surface of theloading sheath 30. As is shown in FIG. 1B, abutment member 34 ispositioned within the lumen of loading sheath 30 a distance d₂, suchthat the remaining opening of the lumen of loading sheath 30 has alength of d₁. Length d₁ also corresponds to the degree of overhang orexposure of stent 10 from the proximal end region 31 of loading sheath30 that is required for affixation of the cover 20 to the stent 10. Thecover 20 is concentrically positioned over the ablumenal surface of theloading sheath 30 and a proximal end of the cover 20 is aligned with theproximal end of the stent 10, such that the loading sheath 30 ispositioned intermediate the stent 10 and the cover 20, with the exposedproximal end 11 of the stent 10 and the proximal end 21 of the cover 20being in adjacent proximity therebetween. Therefore, as shown in thecircled portion of FIG. 1C, after cover 20 has been loaded over loadingsheath 30, the proximal end region 11 of stent 10 and proximal endregion 21 of cover 20 may be joined without interference from proximalend region 31 of loading sheath 30. FIG. 1D depicts an exploded view ofthe circled region of FIG. 1C, with an example of such a join betweenproximal end region 11 of stent 10 and proximal end region 21 of cover20 shown by solid box 15. Thus FIG. 1D depicts a proximally-joinedcovered stent assembly comprising stent 10 contained within cover 20with a joining point 15 between the proximal end regions of stent 10 andcover 20.

FIGS. 2A-2B depict loading the proximally joined stent 10 and cover 20into a constraining tube 50 and the subsequent formation of a distaljuncture 16 between the stent 10 and the cover 20. FIG. 2A depicts aproximally-joined covered stent assembly prepared as in FIG. 1, whichhas been ejected from the loading sheath 30 by axial movement of thepusher rod 32 and the abutment member 34 within the loading sheath 30.By bringing a constraining tube 50 into co-axial alignment with theloading sheath 30, as the proximally-joined covered stent assembly isejected from the loading sheath 30, it is pushed into the constrainingtube 50. The proximally-joined covered stent assembly is positioned inthe constraining tube 50 such that the assembly extends and is exposedfrom the distal end of the constraining tube 50 a distance d₃. Theexposed distal end of the assembly permits formation of a distaljunction 16 between the stent 10 and the cover 20.

FIGS. 3A-3C depict the preparation of an assembly comprising a cathetersheath 60, a proximally- and distally-joined covered stent 25, a pushermember 80, a guidewire shaft 70 and an atraumatic tip 90. In FIG. 3A, aproximally- and distally-joined covered stent assembly is partiallycontained within a catheter sheath 60. The proximally- anddistally-joined covered stent assembly 25 of FIG. 3A may be obtained asshown in FIGS. 1 and 2. In FIG. 3B, the proximally- and distally-joinedcovered stent assembly of FIG. 3A has been pushed completely withincatheter sheath 60, while in FIG. 3C the assembly 25 of FIG. 3B, aguidewire shaft 70 is co-axially inserted through the central lumen ofthe covered stent assembly 25 and extends beyond the terminal (proximal)end of the pusher member 80 and the catheter sheath 60. An atraumatictip 90 is affixed to a distal end of the guidewire shaft 70 prior toinsertion of the guidewire shaft 70. The atraumatic tip 90 is refractedinto abutting relation with a distal end of the catheter sheath 60,thereby enclosing the covered stent assembly 25 within the cathetersheath 60.

In accordance with the best mode for practicing the invention, cover 20is preferably in its martensitic state and unstrained at roomtemperature, when positioned on the loading sheath 30. The stent 10,however, is preferably austenitic and should be loaded into the loadingsheath 30 in the presence of a cooling medium, e.g., liquid nitrogenbath, dry ice and alcohol bath, flow of chilled gas, etc. The stent inits compressed diameter is strained, thus, in order to operate the othermanipulative steps, needs to be within the constraining tube 50 or thecatheter tube. The protruding proximal or distal ends of the stent will,however, flare slightly as they are exposed to room temperatures afterbeing loaded into the loading sheath 30 and the constraining tube 50.This very slight flare, however, ensures good apposition between thestent 10 and cover 20 and facilitates forming a junction between thestent 10 and the cover 20, such as by resistance spot welding.

FIGS. 4A-4B illustrate loading of the inventive covered stent assembly25 into a catheter sheath 100 which acts to constrain the device fromexpansion. FIG. 4B depicts the proximally- and distally-joined coveredstent assembly prepared as in FIGS. 1A-1D, substantially inserted intoconstraining tube 50.

FIGS. 5A-5B depict the steps in completing the delivery catheterassembly 120 after a pusher member 110 is pre-engaged within thecatheter sheath 100, as assembly of the pusher member 110 after thecovered stent assembly 25 is in the catheter sheath 100 would beimpracticable. The covered stent assembly 25 may then be fully insertedinto the catheter sheath 100 as shown in FIG. 5A, such as by using apusher member similar to the pusher member 34, 32 shown in FIG. 1A, suchthat it abuts or is immediately adjacent to the pusher member 110. Oncethe covered stent assembly 25 is fully inserted into the catheter sheath100 and positioned in so that it abuts or is immediately adjacent to thepusher member, a guidewire shaft 122 is co-axially inserted through thecentral lumen of the covered stent assembly 25 and extends beyond theterminal end of the pusher member 110 and the catheter sheath 100. Anatraumatic tip 130 is affixed to a distal end of the guidewire shaft 122prior to insertion of the guidesire shaft 122. The atraumatic tip 130 isretracted into abutting relation with a distal end of the cathethersheath 100, thereby enclosing the covered stent assembly 25 within thecathether sheath 100.

In accordance with all aspects of the present invention, it is desirablethat joining points 15 or 16 be formed by thermal methods, such as suchas laser welding, plasma welding, resistance welding, and e-beam weldingwhere both the stent 10 and the cover 20 are fabricated of metal orpseudometallic materials, preferably shape memory or superelasticmaterials, most preferably, nickel-titanium alloys. However, where thestent 10 and the cover 20 are dissimilar materials, such asnickel-titanium alloy and stainless steel, welding is generally not anacceptable method for joining nickel-titanium alloy to other materials,such as stainless steel, because brittle intermetallics are formed inthe weld zone. Thus, where nickel-titanium alloy is to be joined toanother biocompatible material, it is desirable to employ soldering,epoxies or adhesives to form the joining point 15. Alternatively, ifwelding dissimilar materials to nickel-titanium is desired, it is knownto provide an interlayer material, such as tantalum, to minimizeformation of brittle intermetallics during welding.

Finally, in accordance with the best mode of the invention and thepreferred embodiment thereof and as illustrated in FIGS. 6A and 6B, itis preferably to configure the stent 10 such that it has proximal anddistal junction points 150 which provide a relatively larger,substantially planar surface area for creating the junction between thecover 20 and the stent 10. The junction points 150 may have a generallyquadrilateral shape in the X-Y axis of either the luminal or abluminalsurface of the stent 10, preferably has the same Z-axis wall thicknessas the remaining portions of the stent 10, and have a slight curvaturecorresponding generally to the curvature of the tubular stent 10. FIG. 7is a photomicrograph illustrating a junction point 150 of a stent 10welded to a cover 20.

Alternatively, as described more fully in co-pending, commonly assignedpatent application U.S. Publication No. US20040186554A1, entitled,“Endoluminal stent having mid-strut interconnecting members” or inco-pending, commonly assigned patent application U.S. Publication No.US20040098094A1, entitled “Implantable graft and methods of making same”the junction points 150 may be projections from terminal proximal and/ordistal cylindrical members forming the tubular stent 10 (See, e.g., FIG.1, element 11 in the '554 Publication or FIG. 27, elements 307 and304a-e in the '094 Publication), each publication is hereby expresslyincorporated by reference.

It is preferable, in accordance with the preferred embodiments of theinvention, that when employing shape memory materials for both the stentand the cover, that the stent and the cover have different transitiontemperatures, such that the stent have its transition temperature belowbody temperature and diametrically expand when exposed to bodytemperature, while the cover preferably has a transition temperatureabove body temperature so that it undergoes detwinned martensiticplastic deformation due to expansion of the stent upon implanting intothe body. Thus, it is preferred that the stent have an A_(f)≦29° C.±3°C. and the cover have an have an A_(f) between about 60 to 100° C. Inthis manner, the cover remains martensitic under all conditions whichare likely to be encountered during manufacture, delivery and afterbeing implanted in vivo. The stent, on the other hand, having an A_(f)less than body temperature, will be constrained in the delivery catheterand readily expand during implantation in vivo, and readily expand themartensitic cover along with the radial expansion of the stent. Sincethe cover and the stent will be affixed to each other, it is desirablethat the stent and the cover exhibit compatible degrees offoreshortening upon radial expansion of the resulting covered stentdevice.

The following examples are provided in order to illustrate thealternative embodiments of the invention, and are not intended to limitthe scope of the invention.

EXAMPLE 1 Preparation of a Proximally- and Distally-Joined StentAssembly Using a Constant Outer Diameter Catheter Sheath

A self-expanding shape memory nickel-titanium stent having a wallthickness of 127 μm, a 0.965 mm inner diameter (“ID”) and 1.168 mm outerdiameter (“OD”) is loaded into a loading sheath of 1.194 mm ID and 1.295mm OD of a loading/welding fixture, and a cover of 1.257 mm OD and 4.5micron wall thickness is loaded over the loading sheath. The proximalend region of the cover is then welded to the proximal end region of thecrimped stent.

The resulting proximally-joined covered stent assembly is slid into thedistal end of a constraining tube having a 1.193 mm ID and 1.295 mm OD.The loading sheath of the loading/welding fixture is then retracted, thedistal end region of the cover is welded to the distal end region of thestent, and the weld is passivated in a nitric acid solution.

The resulting proximally- and distally- joined covered stent assembly isthen slid completely into the constant outer diameter catheter sheath.In one non-limiting embodiment of the present invention, this assemblyis chilled in order to facilitate sliding. A pusher shaft of 0.031″ IDand 0.051″ OD is then inserted from the proximal end of the constantouter diameter catheter sheath, and a guidewire shaft of 0.018″ ID and0.027″ OD comprising a proximal tip is inserted from the distal end ofthe constant outer diameter catheter sheath. Alternatively, theinsertion of the guidewire shaft may precede the insertion of the pushershaft.

EXAMPLE 2 Preparation of a Proximally- and Distally-Joined StentAssembly Using a Tapered Catheter Sheath

A self-expanding shape memory stent having a wall thickness of 127 μm iscrimped to an inner diameter (“ID”) of 0.97 mm with an outer diameter of1.17 mm. The crimped stent is then loaded into a loading sheath having a1.19 mm ID and 1.295 mm OD of a loading/welding fixture, and a cover of1.257 mm OD and 4.5 micron wall thickness is loaded over the loadingsheath. The proximal end region of the cover is then welded to theproximal end region of the crimped stent.

The resulting proximally-joined covered stent assembly is slid into aconstraining tube having a 1.193 mm ID and a 1.295 mm OD. The loadingsheath of the loading/welding fixture is then retracted, the distal endregion of the cover is welded to the distal end region of the stent, andthe weld is passivated in a nitric acid solution.

The resulting proximally- and distally- joined covered stent assembly isthen slid completely into the distal end of a tapered catheter sheathhaving an ID of 1.397 mm and a 1.600 OD distally, tapered to 1.092 IDand 1.295 mm OD proximally, where this tapered catheter sheath containsa preloaded catheter pusher shaft of 0.737 mm ID and 1.295 mm ODdistally, tapered to 0.737 mm ID and 0.991 mm OD proximally. In onenon-limiting embodiment of the present invention, this assembly ischilled in order to facilitate sliding. A guidewire sheath of 0.457 mmID and 0.686 mm OD and including an atraumatic tip is then inserted fromthe distal end of the tapered diameter catheter sheath.

While the present invention has been described with reference to itspreferred embodiments, one of ordinary skill in the relevant art willunderstand that the present invention is not intended to be limited bythese preferred embodiments, and is instead contemplated to include allembodiments consistent with the spirit and scope of the presentinvention as defined by the appended claims.

1. A method for preparing the implantable medical device of claimcomprising: a) loading a stent into a lumen of a loading tube such thata first end region of the stent projects beyond a first terminal end ofthe loading tube; b) loading a cover over the terminal end of theloading tube and slidably engaging the cover onto the loading tube suchthat a first terminal end of the cover is in apposition with the firstend region of the stent that projects beyond the first terminal end ofthe loading tube; c) joining the first end region of the cover to thefirst end region of the stent in a first join to form a covered stentassembly having the first join; d) loading the covered stent assemblyhaving the first join into a restraining tube such that a second endregion of the cover and a second end region of the stent project beyonda terminal end of the restraining tube; and e) joining the second endregion of the cover to the second end region of the stent in a secondjoin to form the implantable medical device.
 2. The method of claim 1,wherein steps c) and e) further comprise the step of forming the firstjoin and the second join by resistance welding.
 3. The method of claim2, further comprising the step of passivating the covered stentassembly.
 4. The method of claim 1, further comprising the step oftransferring the covered stent assembly from the restraining tube into acatheter sheath.
 5. The method of claim 1, further comprising the stepsof: a) disposing a pusher member within the catheter sheath prior toloading the implantable medical device into the catheter sheath; b)sliding the implantable medical device into the catheter sheath suchthat it is at least in adjacent proximity to the pusher member; and c)disposing a guidewire sheath through a central bore in the pusher memberand through a central lumen of the implantable medical device.
 6. Themethod of claim 3, wherein said covering sheath further comprises atapered catheter sheath.
 7. The method of claim 5, further comprising:a) disposing a pusher member within the tapered catheter sheath prior toloading the implantable medical device into the catheter sheath; b)sliding the implantable medical device into the tapered catheter sheathsuch that it is at least in adjacent proximity to the pusher member; andc) disposing a guidewire sheath through a central bore in the pushermember and through a central lumen of the implantable medical device. 8.A method of joining a stent with a stent cover, comprising the steps of:a) loading a stent into a lumen of a loading tube such that a first endregion of the stent projects beyond a first terminal end the loadingtube; b) loading a cover over the terminal end of the loading tube andslidably engaging the cover onto the loading tube such that a firstterminal end of the cover is in apposition with the first end region ofthe stent that projects beyond the first terminal end of the loadingtube; c) joining the first end region of the cover to the first endregion of the stent in a first join to form a covered stent assemblyhaving the first join.
 9. The method of claim 8, wherein step c) furthercomprise the step of forming the first join and the second join byresistance welding.
 10. The method of claim 9, further comprising thestep of passivating the first join and the second join.
 11. Animplantable covered-stent, comprising: a) a self-expanding stent havingstructural members and a length defined between a most proximal vertexand a most distal vertex of the structural members, at least oneenlarged member projecting from at least one of the most proximal vertexor the most distal vertex, wherein each of the at least one enlargedmembers has a substantially planar surface and a width greater than thewidth of any structural member of the stent, and at least onefenestration is disposed between the proximal vertex and the distalvertex; and b) a metal cover member having a proximal end region, adistal end region, wall surfaces and a plurality of openings passingthrough the wall surfaces, wherein each of the plurality of openings hasan open surface area less than an open surface area of the at least onefenestration; wherein the proximal end region of said metal cover isjoined by a thermal method in a first join to the at least one enlargedproximal member, and the distal end region of the metal cover is joinedby a thermal method in a second join to the at least one enlarged distalmember, wherein the stent and the metal cover member are formed of thesame biocompatible metal, and wherein the metal cover at least partiallyoccludes the at least one fenestration to form an implantablecovered-stent.
 12. The implantable medical device of claim 11, whereinthe stent and the metal cover have compatible degrees of foreshortening.13. The implantable medical device of claim 11, wherein said stent andsaid metal cover are each composed of at least one material selectedfrom the group consisting of titanium, vanadium, aluminum, nickel,tantalum, zirconium, chromium, silver, gold, silicon, magnesium,niobium, scandium, platinum, cobalt, palladium, manganese, molybdenumand alloys thereof, zirconium-titanium-tantalum alloys, nickel-titaniumalloys, cobalt-chromium alloys and stainless steel.